ClinicalTrials.gov record NCT06879665

TANDem-2: Closing the Gap to Interventions for TAND

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

TANDem-2: Closing the Gap to Interventions for TAND

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationAustralia, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A small pilot study testing whether a brief, 3-week online caregiver program (Well-Beans) can be delivered feasibly and is acceptable to adult caregivers of people with Tuberous Sclerosis Complex (TSC). Sessions are three weekly 2-hour meetings run via a secure Zoom platform in English. The study uses a single-group pre-test/post-test design with immediate post-intervention and 3- and 6-month follow-ups. Attendance, feedback forms, and standard questionnaires will be collected.

What it is studying. The study is testing the feasibility, acceptability, and preliminary impact of an Acceptance and Commitment Therapy (ACT)-based, 3-session online program (Well-Beans) for adult caregivers of individuals with TSC, measured by attendance, feedback, and changes on measures of psychological flexibility, depression, anxiety, wellbeing, and resilience.

What the researchers hope to learn. To determine whether the brief online ACT-based caregiver program can be delivered feasibly and is acceptable, and whether preliminary data suggest changes in caregiver psychological flexibility, depression, anxiety, wellbeing, and resilience.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The goal of this pilot study is to determine the feasibility, acceptability and impact of a brief behavioral intervention - the "Well-Beans for Caregivers" program, for adult caregivers of individuals with tuberous sclerosis complex (TSC) of any age. The main questions of the study are:

  • Can this innovative, ultra-brief caregiver well-being intervention be delivered feasibly to caregivers via an online modality?
  • How do the caregivers experience the program (acceptability)?
  • Does limited efficacy testing suggest the program has an impact on caregiver's well-being?

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Behavioral
  • Well-Beans for Caregivers Program

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Adult caregiver of an individual with Tuberous Sclerosis Complex (TSC) of any age

Exclusion criteria

  • Not an adult caregiver of an individual with TSC

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

The investigators hypothesize that an innovative, ultra-brief caregiver wellbeing intervention developed for caregivers of children with developmental disabilities can be adapted as a universal caregiver wellbeing intervention in tuberous sclerosis complex (TSC), that it can be delivered feasibly in an online modality, and will result in changes in key caregiver wellbeing factors. To test these hypotheses, the researchers will adapt the 3-session 'Well-Beans for Caregivers' program through a participatory method with the TAND consortium (the TAND consortium is an international group of clinical and research professionals as well as family members living with individuals with TSC - TAND stands for TSC-Associated Neuropsychiatric Disorders - see tandconsortium.org). The input from the TAND Consortium will be augmented by members of TSCi (Tuberous Sclerosis International), the global network of TSC non-profit organizations. For step 2 (pilot intervention), two specialist facilitators and four trainee observers will deliver the 3-session program using ZoomPro, a secure online platform to two groups of 10-12 caregivers. Caregivers are those who provide long-term, day-to-day support and care, and this group includes parents, partners, relatives, or other family members (not paid professional caregivers). These sessions will not be recorded to ensure that participants can join the program without feeling concerned about being recorded. Data collection will use a quasi-experimental pre-post-test design. Eligible and consented participants will therefore complete baseline data as 'pre-test' and then 'post-test' data after the 3-week intervention. Following this, they will complete 3-month and 6-month data collection. Caregiver wellbeing measures will only include open access and freely available measures. The program as well as data collection will be conducted in English.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take part in a three-week online program made of three weekly 2-hour group sessions delivered via ZoomPro (sessions will not be recorded). Complete brief questionnaires and bespoke feedback forms before the program (baseline), immediately after the 3-session program, and again at 3 and 6 months; attendance at each session will be tracked. Sessions are run by two specialist facilitators with trainee observers. Measures used are open-access questionnaires (for example Psy-Flex, PHQ-9, GAD-7, WHO-5, Brief Resilience Scale).

How the study is structured. Interventional, single-group pilot: all participants receive the same 3 weekly 2-hour online sessions (no randomization, no masking). Participants complete baseline (pre-test) measures, immediate post-test measures, and follow-up measures at 3 and 6 months. Primary measures are attendance and bespoke feasibility/acceptability feedback forms; secondary measures are established questionnaires (e.g., Psy-Flex, PHQ-9, GAD-7, WHO-5, Brief Resilience Scale). Sessions will be delivered via a secure online platform and are not recorded.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says participants are enrolled by invitation. Who decides who is invited, and how?
  • The listed sites are in Australia, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on tuberous sclerosis complex

Clinical trials30 trials listed for tuberous sclerosis complexEvery trial the registry lists for tuberous sclerosis complex, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in tuberous sclerosis complex researchLatest monthly update: September 2026. Includes: CBD add-on therapy. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 15, 2025
Primary completion
Dec 31, 2026 (estimated)
Study completion
Jul 15, 2027 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Sep 22, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Vrije Universiteit Brussel
Principal investigator
Prof Anna Jansen, Professor
Vrije Universiteit Brussel
Collaborators
  • University of Cape Town
  • United States Department of Defense

Participating sites (2)

  • TSC Alliance

    Silver Spring, Maryland, 20910 · United States

  • Tuberous Sclerosis Australia

    Beverly Hills, New South Wales, 2209 · Australia

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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